MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for SKIN CLASSIC manufactured by Clarebend, Inc..
[177030004]
My daughter went for a regular facial. The facialist performed a 'new treatment' on her with a machine called skin classic. It was painful and left her with pitted scars and burn marks on her entire chin. We visited both a dermatologist whom she sees regularly and after that a plastic surgeon. They both were shocked at the damage that was done to my daughter's chin. She will now need laser treatment at least 6 rounds and both drs felt it would never actually be right. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092595 |
| MDR Report Key | 9641798 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-26 |
| Date of Event | 2019-12-21 |
| Date Added to Maude | 2020-01-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIN CLASSIC |
| Generic Name | EPILATOR, HIGH FREQUENCY, NEEDLE TYPE |
| Product Code | KCW |
| Date Received | 2020-01-28 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLAREBEND, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-28 |